News Nevada State Board of Pharmacy

October 2020

Nevada State

News

Board of Pharmacy

Published to promote compliance of pharmacy and drug law

985 Damonte Ranch Pkwy, Ste 206 ? Reno, NV 89521 ? Phone: 775/850-1440 ? Fax: 775/850-1444

Board Members

Helen Park, PharmD, RPh, Henderson....................President Wayne Mitchell, PharmD, RPh, Carson City...............Board.

Member-Treasurer Richard Tomasso, Las Vegas..........................Public Member Krystal Freitas, PharmD, RPh, Las Vegas..... Board Member Gener Tejero, RPh, Henderson....................... Board Member Rolf Zakariassen, RPh, Reno......................... Board Member Jade Jacobo, PharmD, JD, RPh, Las Vegas.. Board Member

Pharmacists' Vital Role in Influenza Immunization in Nevada

From the 2015-2016 influenza (flu) season to the 2019-2020 flu season, the number of patients in Nevada who received a flu vaccine at a pharmacy increased by nearly 150,000.

During the 2019-2020 flu season, 772,736 patients received a flu vaccine in Nevada. Pharmacists administered a flu vaccine to 351,765 patients, which is 45.5% of all patients who got a flu vaccine in the state.

The above data demonstrates how vital pharmacists are to flu vaccine administration, which will be more important than ever during the 2020-2021 flu season.

NV Vol. 31, No. 3

The Nevada State Immunization Program (NSIP) works with partners across the state to increase access to immunization services and ensure that Nevadans are protected from vaccine-preventable diseases. This work has become even more important during the coronavirus disease 2019 (COVID-19) pandemic as we prepare for the 2020-2021 flu season and the COVID-19 vaccine response.

Increasing flu vaccination coverage in Nevada this fall and winter will decrease stress on public health and health care, decrease doctor visits and hospitalizations, decrease individuals seeking diagnostics, and minimize the risk of coinfection with COVID-19.

NSIP recognizes the important and trusted role that pharmacists play in the immunization community. Not only can they strategically advance public health through immunization advocacy and reach children, adults, and at-risk populations alike, they are well positioned to increase access to immunization services with evening and weekend hours and convenient locations. Additionally, pharmacists are in a strategic position to strongly promote flu vaccination, particularly among vulnerable populations that are at high risk for severe COVID-19 illness and/or flu complications and essential workers who, because of where they work, are at higher risk of COVID-19 and flu infection.

The high-risk populations include

Adults with underlying health conditions

Minority populations (African Americans and Hispanics)

Adults 65 years and older

Children five years and younger

Pregnant women

Multigenerational and close-quartered households with high-risk children or adults

Consult the following resources from the Centers for Disease Control and Prevention (CDC) for more details on these populations:

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FOUNDATION

National Pharmacy Compliance News

October 2020

The applicability of articles in the National Pharmacy Compliance News to a particular state or jurisdiction can only be ascertained by examining the law of

such state or jurisdiction.

NABPF

National Association of Boards

of Pharmacy Foundation

FDA Recommends Health Care Providers Discuss Naloxone With Patients Receiving Opioids, OUD Treatment

Recognizing the importance of discussing naloxone with patients receiving opioids or medications to treat opioid use disorder (OUD), Food and Drug Administration (FDA) recommends that health care providers include such discussions as a routine part of prescribing these medications. Further, the agency is requiring label changes to these medications to include this recommendation. The revised labels will encourage health care providers to discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. The labeling changes also suggest that providers prescribe naloxone to patients being prescribed opioids who are at increased risk of opioid overdose.

"Even during this global pandemic, we have continued to prioritize addressing the opioid crisis," said FDA Commissioner Stephen M. Hahn, MD, in a press release. "Today's action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose. We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting opioid overdose and death in the hands of those who need it most ? those at increased risk of opioid overdose and their friends and family."

The complete list of changes is available through an July 2020 Drug Safety Communication.

Proposed Rule to Require Electronic Submission of DEA Form 106

A proposed rule requiring accurate electronic submission of DEA Form 106 was published by Drug Enforcement Administration (DEA) in the Federal Register on July 29, 2020. The form, used by DEA registrants to report thefts or significant losses of controlled substances (CS), would also need to be submitted within a 15-day time period under the proposed rule. DEA registrants who experience theft or loss of CS would

still be required to notify the DEA Field Division Office in their area, in writing, within one business day of discovery. According to the announcement published in the Federal Register, this requirement will impact the remaining 0.5% of DEA Form 106 responses that are reported by paper.

Inappropriate FentaNYL Patch Prescriptions at Discharge for OpioidNa?ve, Elderly Patients

This column was prepared by the Institute for Safe Medication Practices (ISMP), an ECRI affiliate. Have you experienced a medication error or close call? Report such incidents in confidence to ISMP's National Medication Errors Reporting Program online at or by email to ismpinfo@ to activate an alert system that reaches manufacturers, the medical community, and FDA. To read more about the risk-reduction strategies that you can put into practice today, subscribe to the ISMP Medication Safety Alert!? newsletters at .

ISMP recently heard from a long-term care (LTC) pharmacy about an increase in the prescribing of transdermal fentaNYL patches for elderly patients. In most cases, the pharmacists reviewing the patients' orders determined that the fentaNYL patches had been inappropriately prescribed for opioid-na?ve patients, sometimes to treat acute pain rather than chronic pain. One of the more common underlying causes appears to be a knowledge deficit about the dangers of prescribing this opioid analgesic to opioid-na?ve patients. Several of the events began in a hospital, with opioid-na?ve patients receiving prescriptions for fentaNYL patches after treatment in an emergency department (ED) or upon discharge and transfer to a LTC facility. Prescribing a fentaNYL patch to elderly, opioid-na?ve patients can result in fatal or life-threatening respiratory depression and overdose.

In one event, an 88-year-old resident from a LTC facility fell and was taken to a local hospital ED, where multiple rib fractures were diagnosed. Upon discharge

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National Pharmacy Compliance News

October 2020

from the ED, the resident was prescribed a fentaNYL patch, 25 mcg/hour, every 72 hours. At the LTC facility, a consultant pharmacist reviewed the medication orders and the resident's medication history. The pharmacist determined that the resident had not received a prescription for opioids in the past year, revealing he was opioid-na?ve. The consultant pharmacist contacted the prescribing ED physician to discuss the order for the fentaNYL patch. The ED physician reported that the resident had received "three small IV push doses" of fentaNYL in the ED, mistakenly believing this meant the resident was opioid-tolerant.

Additionally, the ED physician had prescribed the fentaNYL patch because the resident had a documented allergy to codeine. The ED physician mistakenly believed the fentaNYL patch was the only viable option. The consultant pharmacist clarified that the LTC records indicated that the resident had experienced mild nausea and an upset stomach while taking HYDROcodone and acetaminophen when he was younger, which is not an allergy but rather a mild intolerance. The ED physician changed the resident's analgesic to oral oxyCODONE 5 mg as needed every four to six hours.

Reliance on product labeling and practitioner education alone will not prevent life-threatening errors with fentaNYL patches. Yes, health care practitioners should be educated about safe prescribing, and their competency should be verified as a prerequisite to prescribing. But there will always be those who are unaware of the risks they take prescribing fentaNYL patches to opioid-na?ve patients to treat acute pain. Thus, system safeguards must be established to avoid the risk of harm.

FentaNYL patches should only be prescribed for patients who are opioid-tolerant with persistent, moderateto-severe chronic pain that requires around-the-clock, long-term opioid administration. In 2018, ISMP called for the elimination of prescribing fentaNYL patches for opioid-na?ve patients and/or patients with acute pain in our Targeted Medication Safety Best Practices for Hospitals. In 2020, this best practice was incorporated into a new best practice (No.15) to verify and document the patient's opioid status and type of pain before prescribing and dispensing extended-release opioids.

When entering discharge and transfer orders, interactive alerts requiring confirmation that the patient is opioid-tolerant and experiencing chronic pain might

help prevent inappropriate prescribing, as might hard stops if patients do not meet prescribing criteria. Consider creating a daily list of discharge prescriptions and transfer orders for fentaNYL patches generated from the order entry system, and requiring a hospital pharmacist to review them to verify that the patient is opioid-tolerant and has chronic pain.

Engage patients. Educate all patients prescribed a fentaNYL patch and their caregivers about how to use the patch safely.

SAMHSA Health Privacy Rule Revised to Better Integrate, Coordinate Care for Patients With SUD

A revised Substance Abuse and Mental Health Services Administration (SAMHSA) rule will make it easier for people diagnosed with substance use disorders (SUDs) to receive integrated and coordinated care. The revisions to the agency's Confidentiality of Substance Use Disorder Patient Records regulation, 42 CFR Part 2, advances the integration of health care for individuals with SUDs while maintaining critical privacy and confidentiality protections.

According to a US Department of Health and Human Services (HHS) press release, under Part 2, a federally assisted SUD program may only disclose patient identifying information with the individual's written consent, as part of a court order, or under a few limited exceptions. In addition, health care providers, with patients' consent, will be able to more easily conduct quality improvement, claims management, patient safety, training, and program integrity efforts.

The revised rule modifies several major sections of Part 2, including provisions related to records, consent requirements, and research, among others. For a list of changes in the final rule, visit the HHS Fact Sheet.

HHS Assistant Secretary for Mental Health and Substance Use Elinore F. McCance-Katz, MD, PhD, the head of SAMHSA, further stated, "Modernizing 42 CFR Part 2 will strengthen the nation's efforts to reduce opioid misuse and abuse and to support patients and their families confronting substance use disorders. The rule will make it easier for primary care clinicians to treat individuals with substance use disorders."

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Nevada State Board of Pharmacy News

October 2020

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People at increased risk for severe COVID-19 illness

People at high risk for flu complications

The most common factors that contribute to low flu vaccine uptake include concerns about vaccine effectiveness and risk of side effects, including fear of contracting flu illness from the vaccine. A health care provider recommendation is one of the most important factors in patients accepting a vaccine. Pharmacists should help patients understand the facts about how dangerous the flu can be and how important vaccination is in preventing the flu and reducing the severity of illness if the patient still gets the flu. Educating patients about the effectiveness and safety of the flu vaccine and dispelling misinformation and myths can empower them to make informed decisions about their health and ease fears about potential risks and side effects.

NSIP appreciates all that pharmacists do to leverage their position as trusted and accessible immunization providers and to proactively discuss and recommend immunizations to their patients during the flu season, the COVID-19 pandemic, and beyond to keep Nevadans healthy and protected from vaccine-preventable diseases. Visit the following links for resources to supplement immunization efforts:

CDC Vaccination Guidance During a Pandemic

Immunize Nevada Healthcare Professionals Flu Toolkit (includes links to CDC and other online communication and practice resources)

Proposed Amendments to Existing Regulations Permitting Pharmaceutical Technicians to Administer Immunizations

By Courtney Lee, General Counsel

The Honorable Governor Steve Sisolak declared a public health emergency on March 12, 2020, due to the COVID-19 pandemic. Accordingly, it is necessary for the Nevada State Board of Pharmacy to anticipate the need for widespread deployment of the COVID-19 vaccine when it becomes available.

Currently, pharmacists may compound and dispense prescriptions, but they are also authorized to administer immunizations under a physician's established written protocol. See Nevada Administrative Code (NAC) 639.2971. In anticipation of the increased demand for vaccine services, the Board has passed an emergency regulation, which can be found on the COVID-19 page at bop..

This regulation permits pharmaceutical technicians who have completed the required training to administer immunizations under the direct supervision of a pharmacist. This regulation will be important to the state's ability to safely administer vaccinations on a large scale to Nevada's population when a COVID-19 vaccine is developed. In addition, the amendment will facilitate the administration of other lifesaving vaccinations to Nevada's population.

This emergency regulation modifies the existing regulation in the following ways:

A pharmaceutical technician under the direct and immediate supervision of a pharmacist may administer immunizations under the conditions prescribed in NAC 639.2971 if he or she has received the training required by NAC 639.2973 and the continuing education required by NAC 639.2974.

[Furthermore,] A pharmaceutical technician may administer immunizations by an intranasal, intramuscular or subcutaneous injection under the direct and immediate supervision of a pharmacist who has subscribed to a written protocol established by a physician if the pharmacist has determined, in his or her professional judgment, that the patient should be immunized. A record of each immunization administered by the pharmaceutical technician must be maintained in the manner prescribed by NAC 639.2977.

The emergency regulation will be effective for 120 days from the effective date of September 11, 2020. In addition to the emergency regulation, the Board is working on adopting a permanent regulation (Legislative Counsel Bureau File No. R142-20) allowing pharmacy technicians to perform the same activities on a permanent basis. The emergency regulation will bridge the time gap for a permanent regulation to be enacted.

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The Nevada State Board of Pharmacy News is published by the Nevada State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation? (NABPF?) to promote compliance of pharmacy and drug law. The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of NABPF or the Board unless expressly so stated.

J. David "Dave" Wuest, RPh - State News Editor

Lemrey "Al" Carter, PharmD, MS, RPh - National News Editor & Executive Editor

Amy Sanchez - Communications Manager

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